29.12.2001 EN Official Journal of the European Communities L 345/7

COUNCIL REGULATION (EC) No 2584/2001 of 19 December 2001 amending Annexes I and III of Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION, (4) Regulation (EEC) No 2377/90 provides that the estab- lishment of maximum residue limits shall in no way prejudice the application of other relevant Community Having regard to the Treaty establishing the European legislation. Community,

Having regard to Council Regulation (EEC) No 2377/90 of 26 (5) For the purpose of monitoring residues, as provided for June 1990 laying down a Community procedure for the estab- in appropriate Community legislation, maximum residue lishment of maximum residue limits of veterinary medicinal limits should usually be established for the target tissues products in foodstuffs of animal origin (1), and in particular of liver or kidney. However, as the liver and kidney are Article 7 thereof, frequently removed from carcasses moving in inter- national trade, maximum residue limits should conse- quently be established always for muscle or fat tissues. Having regard to the proposal from the Commission,

(6) The substances chlormadinone, flugestone acetate and Whereas: altrenogest are hormones and are therefore subject to restrictions and control of use as provided for in Council Directive 96/22/EC of 29 April 1996 concerning the (1) In accordance with Regulation (EEC) No 2377/90, maximum residue limits are to be established progres- prohibition on the use in stockfarming of certain sively for all pharmacologically active substances which substances having a hormonal or thyrostatic action and 2 are used within the Community in veterinary medicinal of β-agonists ( ). Under certain conditions, these products intended for administration to food-producing hormones may be administered to farm animals for animals. therapeutic or zootechnical purposes only. In particular, these conditions require the administration of these substances by a veterinarian or under his direct responsi- (2) Maximum residue limits should be established only after bility. In addition, the type of treatment, the types of examination within the Committee for Veterinary Medi- products authorised, the date of treatment and the iden- cinal Products of all the relevant information concerning tity of the animals treated must be officially recorded by the safety of residues of the substance concerned for the the veterinarian. consumer of foodstuffs of animal origin and the impact of residues on the industrial processing of foodstuffs and taking into account all publicly available relevant (7) Furthermore, the conditions laid down in Directive 96/ scientific information concerning the safety of residues 22/EC prohibit the administration of hormones for ther- of the substance concerned for the consumer of food- apeutic or zootechnical purposes to breeding animals stuffs of animal origin, including for example opinions during the fattening period at the end of their reproduc- of the Scientific Committee on Veterinary Measures tive life. Moreover, they provide that meat or products Relating to Public Health, reports from the Joint from animals to which hormones have been adminis- FAO/WHO Expert Committee on Food Additives tered for therapeutic or zootechnical treatment should (JECFA) or reports from internationally renowned not be placed on the market for human consumption research organisations. unless they have been treated in accordance with Directive 96/22/EC and insofar as the withdrawal period laid down was observed before the animals were slaugh- (3) In establishing maximum residue limits for residues of tered. veterinary medicinal products in foodstuffs of animal origin, it is necessary to specify the animal species in which residues may be present, the levels at which they may be present in each of the relevant tissues obtained (8) The overall evaluation of the available risk assessments from the treated animal (target tissue) and the nature of of these substances and of the entire body of available the residue which is relevant for the monitoring of scientific information and data indicate that, as concerns residues (marker residue). In the case of veterinary medi- the excess intake of hormone residues and their metabo- cinal products intended for use in lactating animals lites, and in view of the intrinsic properties of hormones maximum residue limits shall be established for milk. and epidemiological findings, a risk to the consumer has been identified. (1) OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commis- sion Regulation (EC) No 2162/2001 (OJ L 291, 8.11.2001, p. 9). (2) OJ L 125, 23.5.1996, p. 3. L 345/8 EN Official Journal of the European Communities 29.12.2001

(9) Furthermore, given the intrinsic properties of sexual (12) It is thus considered appropriate, without prejudice to hormones and as it is not possible to exclude that good other provisions of Community law, in particular veterinary practice is not systematically applied, and that Directive 96/22/EC, that chlormadinone and flugestone therefore the authorities should be provided with means acetate (for ovine milk) be inserted into Annex I to of control of illegal use of these hormones, Council Regulation (EEC) No 2377/90 and that, in order to allow Directive 96/23/EC of 29 April 1996 on measures to for the completion of scientific studies, altrenogest and monitor certain substances and residues thereof in live flugestone acetate (for caprine milk) be inserted into animals and animal products (1), requires the authorities Annex III thereto. to carry out investigations in the case of suspected animals or positive laboratory results. (13) However, it has to be stressed that, as a result of new information or a re-assessment of existing information, (10) Taking into account the identified potential adverse Regulation (EEC) No 2377/90 can be amended in order effects to human health from the administration of these to protect human or animal health, in accordance with hormones to farm animals for any purpose and after the procedures provided for in this Regulation. consideration of the current need to continue to make available on the Community market some of these (14) The Standing Committee on Veterinary Medicinal Prod- substances that are currently used for therapeutic or ucts referred to in Article 8 of Regulation (EEC) No zootechnical treatment of farm animals and, taking also 2377/90 has not delivered a favourable opinion on the into account the strict conditions under which Directive Commission proposed measures, 96/22/EC authorises the use of these substances for therapeutic or zootechnical purposes, it is appropriate to proceed with the consideration of these substances HAS ADOPTED THIS REGULATION: under Regulation (EEC) No 2377/90 for the purpose of setting up maximum residue limits. Article 1 (11) Provided that there are no grounds for supposing that Annexes I and III to Regulation (EEC) No 2377/90 are hereby residues of the substance concerned at the level amended as set out in the Annex to this Regulation. proposed present a hazard for the health of the consumer, maximum residue limits should be estab- lished in Annex I or Annex III to Regulation (EEC) No Article 2 2377/90. However, given the overall evaluation on the This Regulation shall enter into force on the third day risk assessments of sexual hormones, as concerns following that of its publication in the Official Journal of the possible excess intake of hormone residues and their European Communities. metabolites, a possible risk to the consumer needs to be regularly reviewed on the basis of any new scientific It shall apply from the sixtieth day following that of its publica- evidence. tion.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 19 December 2001.

For the Council The President A. NEYTS-UYTTEBROECK

(1) OJ L 125, 23.5.1996, p. 10. 29.12.2001 EN Official Journal of the European Communities L 345/9 Other provisions Other provisions mum residue limits have been fixed) rinary medicinal products for which provisional maximum For zootechnical use only For intravaginal use for zootechnical purposes only’ Provisional MRLs expire on 01/01/2003; For zootechnical use only Provisional MRLs expirezootechnical on purposes 01/01/2003; only’ For intravaginal use for Target tissues Target tissues Fat Liver Milk Milk Fat Liver Kidney Fat Liver Kidney Milk g/kg g/kg g/kg g/kg g/kg g/kg g/kg g/kg g/kg g/kg g/kg µ µ µ µ µ µ µ µ µ µ µ MRLs MRLs 4 2 1 3 3 3 3 3 3 1 ANNEX 2,5 Animal species Animal species Bovine Ovine Porcine Equidae Caprine Marker residue Marker residue Chlormadinone Flugetone acetate Altrenogest Flugestone acetate substance(s) substance(s) Pharmacologically active Pharmacologically active ‘6. Agents acting6.1. on Progestogens the reproductive system Chlormadinone Flugestone acetate Flugestone acetate residue limits have been‘6. fixed) Agents acting6.1. on Progestogens the reproductive system Altrenogest A. The following substances are hereby inserted in Annex I to Regulation (EEC) No 2377/90 (List of pharmacologically active substances for which maxi B. The following substances are hereby inserted in Annex III to Regulation (EEC) No 2377/90 (List of pharmacologically active substances used in vete